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Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00835276
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 4, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Fexofenadine 180 mg tablets
Drug: ALLEGRA® 180 mg tablets
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fexofenadine Hydrochloride First Allegra® First
Hide Arm/Group Description 180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period. 180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
Period Title: First Intervention
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: Washout of 7 Days
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: Second Intervention
Started 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title Fexofenadine Hydrochloride First Allegra® First Total
Hide Arm/Group Description 180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period. 180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period. Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
24
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
6
  25.0%
11
  45.8%
17
  35.4%
Male
18
  75.0%
13
  54.2%
31
  64.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
American Indian 1 0 1
White 22 24 46
Hispanic 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 24 48
1.Primary Outcome
Title Cmax = Maximum Observed Concentration.
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 48 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fexofenadine Hydrochloride Allegra®
Hide Arm/Group Description:
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
180 mg Allegra® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: ng/mL
449.6  (216.08) 498.95  (204.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fexofenadine Hydrochloride, Allegra®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 87.96
Confidence Interval 90%
80.15 to 96.53
Estimation Comments To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.
2.Primary Outcome
Title AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 48 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fexofenadine Hydrochloride Allegra®
Hide Arm/Group Description:
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
180 mg Allegra® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2711.8  (1118.2) 2912.63  (1092.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fexofenadine Hydrochloride, Allegra®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 91.47
Confidence Interval 90%
85.15 to 98.26
Estimation Comments To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.
3.Primary Outcome
Title AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 48 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fexofenadine Hydrochloride Allegra®
Hide Arm/Group Description:
180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
180 mg Allegra® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2814.79  (1132.18) 3024.53  (1104.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fexofenadine Hydrochloride, Allegra®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 91.47
Confidence Interval 90%
85.32 to 98.07
Estimation Comments To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager, Biopharmaceutics
Organization: Manager, Biopharmaceutics
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00835276     History of Changes
Other Study ID Numbers: R01-861
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: August 20, 2009